Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers (NCT NCT01340898)

Last Updated: 2019-08-06

Results Overview

The cut-off value for the rSBA titers was ≥ 1:8. Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

753 participants

Primary outcome timeframe

At Month 5 (one month post-dose 3)

Results posted on

2019-08-06

Participant Flow

Out of 753 subjects enrolled, 3 subjects were not vaccinated and hence not considered to have started the study.

Participant milestones

Participant milestones
Measure	Nimenrix 3+1 Group Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix 1+1 Group Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Primary Phase STARTED	376	187	187
Primary Phase COMPLETED	360	178	181
Primary Phase NOT COMPLETED	16	9	6
Booster Phase STARTED	342	166	170
Booster Phase COMPLETED	332	164	163
Booster Phase NOT COMPLETED	10	2	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Nimenrix 3+1 Group Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix 1+1 Group Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Primary Phase Serious Adverse Events	0	0	1
Primary Phase Withdrawal by Subject	8	7	5
Primary Phase Migrated/moved from study area	4	1	0
Primary Phase Lost to Follow-up	4	1	0
Booster Phase Withdrawal by Subject	3	0	4
Booster Phase Migrated/moved from study area	3	0	0
Booster Phase Lost to Follow-up	4	2	3

Baseline Characteristics

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nimenrix 3+1 Group n=376 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix 1+1 Group n=187 Participants Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=187 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Total n=750 Participants Total of all reporting groups
Age, Continuous	8.1 Weeks STANDARD_DEVIATION 1.6 • n=5 Participants	8.1 Weeks STANDARD_DEVIATION 1.7 • n=7 Participants	8.2 Weeks STANDARD_DEVIATION 1.7 • n=5 Participants	8.12 Weeks STANDARD_DEVIATION 1.65 • n=4 Participants
Sex: Female, Male Female	182 Participants n=5 Participants	105 Participants n=7 Participants	95 Participants n=5 Participants	382 Participants n=4 Participants
Sex: Female, Male Male	194 Participants n=5 Participants	82 Participants n=7 Participants	92 Participants n=5 Participants	368 Participants n=4 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	199 Participants n=5 Participants	100 Participants n=7 Participants	99 Participants n=5 Participants	398 Participants n=4 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Mixed Origin	176 Participants n=5 Participants	87 Participants n=7 Participants	87 Participants n=5 Participants	350 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Month 5 (one month post-dose 3)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. This endpoint was specified to be analysed for the Nimenrix 3+1 Group only.

The cut-off value for the rSBA titers was ≥ 1:8. Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=328 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Against Neisseria Meningitidis Serogroups Antibody Titers Greater Than or Equal to (≥) 1:8, One Month Post Dose 3 for the Nimenrix 3+1 Group rSBA-MenA	328 Participants	—	—
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Against Neisseria Meningitidis Serogroups Antibody Titers Greater Than or Equal to (≥) 1:8, One Month Post Dose 3 for the Nimenrix 3+1 Group rSBA-MenC	327 Participants	—	—
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Against Neisseria Meningitidis Serogroups Antibody Titers Greater Than or Equal to (≥) 1:8, One Month Post Dose 3 for the Nimenrix 3+1 Group rSBA-MenW-135	325 Participants	—	—
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Against Neisseria Meningitidis Serogroups Antibody Titers Greater Than or Equal to (≥) 1:8, One Month Post Dose 3 for the Nimenrix 3+1 Group rSBA-MenY	327 Participants	—	—

SECONDARY outcome

Timeframe: At Month 13 (prior booster) and at Month 14 (one month after the booster dose)

The cut-off value for the rSBA titers was ≥ 1:8

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=284 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenW-135, M14	284 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenA, M13	225 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenA, M14	283 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenC, M13	190 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenC, M14	282 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenW-135, M13	225 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenY, M13	240 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenY, M14	284 Participants	—	—

SECONDARY outcome

Timeframe: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)

The cut-off value for the rSBA titers was ≥ 1:128

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=328 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenW-135, M5	313 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenW-135, M13	122 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenW-135, M14	284 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenY, M5	312 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenY, M13	121 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenY, M14	283 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenA, M5	321 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenA, M13	146 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenA, M14	282 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenC, M5	318 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenC, M13	93 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenC, M14	282 Participants	—	—

SECONDARY outcome

Timeframe: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=328 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenA, M5	577.5 Titers Interval 520.7 to 640.6	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenA, M13	71.1 Titers Interval 56.6 to 89.3	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenA, M14	2366.4 Titers Interval 2134.8 to 2623.1	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenC, M5	803.1 Titers Interval 710.4 to 907.8	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenC, M13	33.9 Titers Interval 27.4 to 41.9	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenC, M14	2761.2 Titers Interval 2461.2 to 3097.9	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenW-135, M5	1190.3 Titers Interval 1019.3 to 1390.1	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenW-135, M13	52.0 Titers Interval 42.2 to 64.2	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenW-135, M14	3696.9 Titers Interval 3242.8 to 4214.7	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenY, M5	647.4 Titers Interval 566.6 to 739.6	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenY, M13	66.3 Titers Interval 54.3 to 81.0	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group rSBA-MenY, M14	2778.6 Titers Interval 2472.5 to 3122.5	—	—

SECONDARY outcome

Timeframe: At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose for Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)

The cut-off values for the rSBA antibody titers were ≥ 1:8 and ≥ 1:128

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=163 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=163 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenC, M13, ≥ 1:8	86 Participants	3 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenC, M14, ≥ 1:8	138 Participants	130 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenY, M13, ≥ 1:8	116 Participants	24 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenY, M14, ≥ 1:8	139 Participants	131 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenA, M5, ≥ 1:128	155 Participants	6 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenA, M13, ≥ 1:128	88 Participants	16 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenA, M14, ≥ 1:128	138 Participants	132 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenC, M5, ≥ 1:128	151 Participants	5 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenC, M13, ≥ 1:128	39 Participants	1 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenC, M14, ≥ 1:128	137 Participants	128 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenW-135, M5, ≥ 1:128	151 Participants	4 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenA, M5, ≥ 1:8	161 Participants	6 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenA, M13, ≥ 1:8	107 Participants	19 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenA, M14, ≥ 1:8	138 Participants	133 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenC, M5, ≥ 1:8	162 Participants	6 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenW-135, M5, ≥ 1:8	153 Participants	4 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenW-135, M13, ≥ 1:8	102 Participants	7 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenW-135, M14, ≥ 1:8	139 Participants	131 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenY, M5, ≥ 1:8	161 Participants	16 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenW-135, M13, ≥ 1:128	65 Participants	7 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenW-135, M14, ≥ 1:128	138 Participants	131 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenY, M5, ≥ 1:128	159 Participants	16 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenY, M13, ≥ 1:128	70 Participants	23 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenY, M14, ≥ 1:128	137 Participants	131 Participants	—

SECONDARY outcome

Timeframe: At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=163 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=163 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenC, M14, ≥ 1:8	2525.2 Titers Interval 2102.1 to 3033.3	768.1 Titers Interval 593.0 to 995.0	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenW-135, M5, ≥ 1:8	1255.9 Titers Interval 917.0 to 1720.0	4.6 Titers Interval 4.0 to 5.2	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenY, M13, ≥ 1:8	106.4 Titers Interval 76.4 to 148.1	9.4 Titers Interval 6.8 to 12.9	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenY, M14, ≥ 1:8	2748.6 Titers Interval 2301.4 to 3282.6	4202.5 Titers Interval 3219.9 to 5485.1	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenA, M5, ≥ 1:8	1332.9 Titers Interval 1035.2 to 1716.2	4.8 Titers Interval 4.1 to 5.5	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenA, M13, ≥ 1:8	125.3 Titers Interval 84.4 to 186.1	7.2 Titers Interval 5.5 to 9.3	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenA, M14, ≥ 1:8	2762.3 Titers Interval 2310.3 to 3302.8	2918.7 Titers Interval 2264.6 to 3761.7	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenC, M5, ≥ 1:8	591.6 Titers Interval 482.3 to 725.8	4.7 Titers Interval 4.1 to 5.4	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenC, M13, ≥ 1:8	27.4 Titers Interval 20.6 to 36.6	4.2 Titers Interval 3.9 to 4.4	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenW-135, M13, ≥ 1:8	63.3 Titers Interval 45.6 to 87.9	5.0 Titers Interval 4.2 to 5.8	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenW-135, M14, ≥ 1:8	3144.7 Titers Interval 2636.9 to 3750.4	5240.7 Titers Interval 3855.5 to 7123.7	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups rSBA-MenY, M5, ≥ 1:8	1469.9 Titers Interval 1186.5 to 1821.0	6.3 Titers Interval 5.0 to 7.8	—

SECONDARY outcome

Timeframe: At Month 14 (one month post-booster dose for Nimenrix 3+1 and Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects, who complied with the vaccination schedule at Month 13 (booster dose for Nimenrix 3+1 and Nimenrix 1+1 and first dose in Nimenrix Control) and for whom data concerning immunogenicity endpoint measures were available

Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers \< 1:8 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers \>= 1:8 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination antibody titer.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=275 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=131 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=132 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Booster Responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group rSBA-MenA	248 Participants	108 Participants	125 Participants
Number of Subjects With Booster Responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group rSBA-MenW-135	272 Participants	122 Participants	128 Participants
Number of Subjects With Booster Responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group rSBA-MenY	267 Participants	121 Participants	125 Participants
Number of Subjects With Booster Responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group rSBA-MenC	270 Participants	129 Participants	126 Participants

SECONDARY outcome

Timeframe: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 50% of subjects from each group.

The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=147 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=66 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=59 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups) hSBA-MenA, ≥ 1:4	136 Participants	58 Participants	9 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups) hSBA-MenC, ≥ 1:4	147 Participants	66 Participants	3 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups) hSBA-MenW-135, ≥ 1:4	107 Participants	41 Participants	0 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups) hSBA-MenY, ≥ 1:4	127 Participants	48 Participants	1 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups) hSBA-MenA, ≥ 1:8	136 Participants	58 Participants	8 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups) hSBA-MenC, ≥ 1:8	147 Participants	66 Participants	3 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups) hSBA-MenW-135, ≥ 1:8	107 Participants	41 Participants	0 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups) hSBA-MenY, ≥ 1:8	127 Participants	48 Participants	1 Participants

SECONDARY outcome

Timeframe: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=147 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=66 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=59 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (One Month Post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)) -Randomized Subset of 50% of Subjects of All Three Groups hSBA-MenA	808.0 Titers Interval 683.8 to 954.6	270.5 Titers Interval 205.9 to 355.4	2.6 Titers Interval 2.2 to 3.1
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (One Month Post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)) -Randomized Subset of 50% of Subjects of All Three Groups hSBA-MenC	3970.8 Titers Interval 3144.0 to 5015.1	523.1 Titers Interval 381.5 to 717.3	2.3 Titers Interval 1.9 to 2.9
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (One Month Post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)) -Randomized Subset of 50% of Subjects of All Three Groups hSBA-MenW-135	1514.5 Titers Interval 1277.2 to 1795.8	136.5 Titers Interval 78.4 to 237.6	2.0 Titers Interval 2.0 to 2.0
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (One Month Post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)) -Randomized Subset of 50% of Subjects of All Three Groups hSBA-MenY	1276.2 Titers Interval 1077.3 to 1511.8	194.8 Titers Interval 117.6 to 322.9	2.1 Titers Interval 1.9 to 2.4

SECONDARY outcome

Timeframe: At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)

The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=198 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=92 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=84 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenA, ≥ 1:4, M13	131 Participants	48 Participants	18 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenA, ≥ 1:4, M14	173 Participants	83 Participants	70 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenW-135, ≥ 1:8, M13	123 Participants	53 Participants	1 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenW-135, ≥ 1:8, M14	129 Participants	59 Participants	49 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenY, ≥ 1:4, M14	149 Participants	69 Participants	52 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenA, ≥ 1:8, M13	130 Participants	47 Participants	15 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenC, ≥ 1:4, M13	168 Participants	76 Participants	4 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenC, ≥ 1:4, M14	198 Participants	92 Participants	84 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenW-135, ≥ 1:4, M13	123 Participants	53 Participants	1 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenW-135, ≥ 1:4, M14	129 Participants	59 Participants	49 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenY, ≥ 1:4, M13	137 Participants	60 Participants	4 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenA, ≥ 1:8, M14	173 Participants	83 Participants	69 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenC, ≥ 1:8, M13	168 Participants	75 Participants	4 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenC, ≥ 1:8, M14	198 Participants	92 Participants	84 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenY, ≥ 1:8, M13	137 Participants	60 Participants	4 Participants
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) hSBA-MenY, ≥ 1:8, M14	149 Participants	69 Participants	52 Participants

SECONDARY outcome

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=198 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=92 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=84 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control) hSBA-MenC, M13	209.0 Titers Interval 165.7 to 263.7	150.8 Titers Interval 108.5 to 209.5	2.3 Titers Interval 2.0 to 2.7
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control) hSBA-MenC, M14	15919.1 Titers Interval 13965.3 to 18146.2	13360.1 Titers Interval 10952.9 to 16296.4	363.3 Titers Interval 269.4 to 490.1
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control) hSBA-MenA, M13	64.6 Titers Interval 48.8 to 85.5	20.8 Titers Interval 13.5 to 32.2	3.2 Titers Interval 2.6 to 3.8
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control) hSBA-MenA, M14	2318.6 Titers Interval 1991.7 to 2699.1	1415.6 Titers Interval 1140.2 to 1757.5	196.3 Titers Interval 140.5 to 274.2
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control) hSBA-MenW-135, M13	307.9 Titers Interval 262.9 to 360.6	428.6 Titers Interval 328.4 to 559.2	2.1 Titers Interval 1.9 to 2.3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control) hSBA-MenW-135, M14	8761.8 Titers Interval 7431.3 to 10330.5	9015.6 Titers Interval 7045.2 to 11537.1	221.7 Titers Interval 140.6 to 349.5
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control) hSBA-MenY, M13	363.2 Titers Interval 309.9 to 425.7	389.2 Titers Interval 292.3 to 518.1	2.6 Titers Interval 2.0 to 3.5
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control) hSBA-MenY, M14	5989.3 Titers Interval 5281.0 to 6792.6	5977.6 Titers Interval 4746.8 to 7527.6	281.5 Titers Interval 171.9 to 460.9

SECONDARY outcome

Timeframe: At Month 14 (one month after the booster dose in Nimenrix 3+1 and Nimenrix 1+1 and post-vaccination in Nimenrix Control Group)

Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers \< 1:4 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers \>= 1:4 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=163 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=75 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=65 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Booster Responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group hSBA-MenC, Total	163 Participants	73 Participants	65 Participants
Number of Subjects With Booster Responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group hSBA-MenW-135, Total	106 Participants	40 Participants	37 Participants
Number of Subjects With Booster Responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group hSBA-MenA, Total	130 Participants	61 Participants	51 Participants
Number of Subjects With Booster Responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group hSBA-MenY, Total	115 Participants	45 Participants	30 Participants

SECONDARY outcome

Timeframe: At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)

The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=82 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=42 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=37 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-6A, M14	51 Participants	25 Participants	24 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-6B, M5	81 Participants	41 Participants	37 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-1, M5	82 Participants	42 Participants	37 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-1, M13	36 Participants	19 Participants	19 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-1, M14	61 Participants	29 Participants	29 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-4, M5	82 Participants	42 Participants	37 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-4, M13	38 Participants	22 Participants	20 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-4, M14	61 Participants	30 Participants	29 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-5, M5	81 Participants	42 Participants	37 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-5, M13	32 Participants	18 Participants	17 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-5, M14	60 Participants	29 Participants	27 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-6A, M5	51 Participants	31 Participants	22 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-6A, M13	44 Participants	26 Participants	16 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-6B, M13	55 Participants	31 Participants	22 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-6B, M14	61 Participants	30 Participants	28 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-7F, M5	82 Participants	42 Participants	37 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-7F, M13	55 Participants	32 Participants	23 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-7F, M14	61 Participants	29 Participants	29 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-9V, M5	82 Participants	42 Participants	37 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-9V, M13	47 Participants	24 Participants	17 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-9V, M14	61 Participants	29 Participants	29 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-14, M5	82 Participants	42 Participants	36 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-14, M13	56 Participants	33 Participants	25 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-14, M14	61 Participants	30 Participants	29 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-18C, M5	81 Participants	42 Participants	37 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-18C, M13	43 Participants	20 Participants	19 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-18C, M14	61 Participants	29 Participants	29 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-19A, M5	49 Participants	26 Participants	27 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-19A, M13	41 Participants	23 Participants	20 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-19A, M14	57 Participants	27 Participants	27 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-19F, M5	81 Participants	42 Participants	36 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-19F, M13	57 Participants	33 Participants	25 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-19F, M14	61 Participants	30 Participants	29 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-23F, M5	66 Participants	42 Participants	35 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-23F, M13	42 Participants	25 Participants	18 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). anti-23F, M14	45 Participants	23 Participants	21 Participants

SECONDARY outcome

Timeframe: At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)

The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=82 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=42 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=37 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-14, M14	61 Participants	29 Participants	28 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-18C, M5	79 Participants	41 Participants	36 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-1, M5	76 Participants	41 Participants	34 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-1, M13	12 Participants	5 Participants	8 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-1, M14	61 Participants	29 Participants	28 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-4, M5	81 Participants	41 Participants	37 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-4, M13	17 Participants	5 Participants	10 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-4, M14	58 Participants	29 Participants	29 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-5, M5	72 Participants	32 Participants	28 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-5, M13	10 Participants	5 Participants	5 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-5, M14	49 Participants	23 Participants	26 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-6A, M5	36 Participants	20 Participants	13 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-6A, M13	26 Participants	10 Participants	11 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-6A, M14	47 Participants	22 Participants	23 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-6B, M5	73 Participants	40 Participants	35 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-6B, M13	37 Participants	23 Participants	15 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-6B, M14	61 Participants	28 Participants	28 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-7F, M5	81 Participants	42 Participants	37 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-7F, M13	38 Participants	17 Participants	14 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-7F, M14	61 Participants	29 Participants	28 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-9V, M5	79 Participants	40 Participants	36 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-9V, M13	19 Participants	10 Participants	9 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-9V, M14	59 Participants	28 Participants	28 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-14, M5	80 Participants	41 Participants	36 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-14, M13	44 Participants	28 Participants	21 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-18C, M13	18 Participants	9 Participants	11 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-18C, M14	61 Participants	27 Participants	29 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-19A, M5	28 Participants	14 Participants	13 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-19A, M13	25 Participants	15 Participants	5 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-19A, M14	52 Participants	21 Participants	22 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-19F, M5	80 Participants	42 Participants	36 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-19F, M13	52 Participants	30 Participants	20 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-19F, M14	61 Participants	30 Participants	29 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-23F, M5	62 Participants	42 Participants	32 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-23F, M13	28 Participants	14 Participants	12 Participants
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) anti-23F, M14	45 Participants	23 Participants	20 Participants

SECONDARY outcome

Timeframe: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL)

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=82 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=42 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=37 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Anti-pneumococcal Antibody Concentrations anti-6A, M14	1.7 μg/mL Interval 1.3 to 2.3	1.4 μg/mL Interval 0.9 to 2.1	1.6 μg/mL Interval 1.0 to 2.5
Anti-pneumococcal Antibody Concentrations anti-14, M5	5.2 μg/mL Interval 4.1 to 6.5	6.0 μg/mL Interval 4.4 to 8.0	7.0 μg/mL Interval 4.9 to 10.0
Anti-pneumococcal Antibody Concentrations anti-19A, M5	0.2 μg/mL Interval 0.2 to 0.3	0.2 μg/mL Interval 0.2 to 0.4	0.2 μg/mL Interval 0.2 to 0.3
Anti-pneumococcal Antibody Concentrations anti-19A, M13	0.3 μg/mL Interval 0.2 to 0.4	0.3 μg/mL Interval 0.2 to 0.4	0.2 μg/mL Interval 0.1 to 0.3
Anti-pneumococcal Antibody Concentrations anti-19F, M14	8.0 μg/mL Interval 6.2 to 10.2	6.9 μg/mL Interval 4.5 to 10.6	9.8 μg/mL Interval 6.8 to 14.2
Anti-pneumococcal Antibody Concentrations anti-23F, M5	1.4 μg/mL Interval 1.0 to 1.9	1.8 μg/mL Interval 1.4 to 2.4	1.5 μg/mL Interval 1.0 to 2.2
Anti-pneumococcal Antibody Concentrations anti-1, M5	1.3 μg/mL Interval 1.1 to 1.6	1.4 μg/mL Interval 1.1 to 1.8	1.5 μg/mL Interval 1.1 to 2.1
Anti-pneumococcal Antibody Concentrations anti-1, M13	0.2 μg/mL Interval 0.1 to 0.2	0.2 μg/mL Interval 0.1 to 0.2	0.2 μg/mL Interval 0.2 to 0.3
Anti-pneumococcal Antibody Concentrations anti-1, M14	2.1 μg/mL Interval 1.6 to 2.6	1.7 μg/mL Interval 1.2 to 2.5	2.2 μg/mL Interval 1.5 to 3.2
Anti-pneumococcal Antibody Concentrations anti-4, M5	1.7 μg/mL Interval 1.5 to 2.0	1.8 μg/mL Interval 1.4 to 2.2	1.8 μg/mL Interval 1.3 to 2.5
Anti-pneumococcal Antibody Concentrations anti-4, M13	0.2 μg/mL Interval 0.2 to 0.3	0.2 μg/mL Interval 0.2 to 0.3	0.3 μg/mL Interval 0.2 to 0.4
Anti-pneumococcal Antibody Concentrations anti-4, M14	2.4 μg/mL Interval 1.8 to 3.1	2.4 μg/mL Interval 1.8 to 3.1	3.1 μg/mL Interval 2.3 to 4.2
Anti-pneumococcal Antibody Concentrations anti-5, M5	0.6 μg/mL Interval 0.6 to 0.7	0.6 μg/mL Interval 0.5 to 0.7	0.7 μg/mL Interval 0.5 to 0.9
Anti-pneumococcal Antibody Concentrations anti-5, M13	0.2 μg/mL Interval 0.1 to 0.2	0.2 μg/mL Interval 0.1 to 0.2	0.2 μg/mL Interval 0.1 to 0.2
Anti-pneumococcal Antibody Concentrations anti-5, M14	0.7 μg/mL Interval 0.6 to 0.9	0.5 μg/mL Interval 0.4 to 0.7	0.7 μg/mL Interval 0.5 to 1.0
Anti-pneumococcal Antibody Concentrations anti-6A, M5	0.3 μg/mL Interval 0.3 to 0.4	0.4 μg/mL Interval 0.3 to 0.6	0.3 μg/mL Interval 0.2 to 0.4
Anti-pneumococcal Antibody Concentrations anti-6A, M13	0.3 μg/mL Interval 0.2 to 0.4	0.3 μg/mL Interval 0.2 to 0.4	0.2 μg/mL Interval 0.2 to 0.4
Anti-pneumococcal Antibody Concentrations anti-6B, M5	1.8 μg/mL Interval 1.4 to 2.3	1.7 μg/mL Interval 1.3 to 2.4	1.8 μg/mL Interval 1.3 to 2.5
Anti-pneumococcal Antibody Concentrations anti-6B, M13	0.6 μg/mL Interval 0.4 to 0.7	0.5 μg/mL Interval 0.4 to 0.7	0.4 μg/mL Interval 0.3 to 0.7
Anti-pneumococcal Antibody Concentrations anti-6B, M14	3.8 μg/mL Interval 3.1 to 4.8	2.4 μg/mL Interval 1.7 to 3.5	3.4 μg/mL Interval 2.2 to 5.2
Anti-pneumococcal Antibody Concentrations anti-7F, M5	2.5 μg/mL Interval 2.2 to 3.0	2.2 μg/mL Interval 1.8 to 2.7	2.8 μg/mL Interval 2.1 to 3.7
Anti-pneumococcal Antibody Concentrations anti-7F, M13	0.4 μg/mL Interval 0.4 to 0.5	0.4 μg/mL Interval 0.3 to 0.5	0.4 μg/mL Interval 0.3 to 0.6
Anti-pneumococcal Antibody Concentrations anti-7F, M14	3.5 μg/mL Interval 2.9 to 4.2	2.2 μg/mL Interval 1.6 to 3.1	3.4 μg/mL Interval 2.4 to 4.9
Anti-pneumococcal Antibody Concentrations anti-9V, M5	1.2 μg/mL Interval 1.0 to 1.4	1.2 μg/mL Interval 1.0 to 1.5	1.3 μg/mL Interval 1.0 to 1.7
Anti-pneumococcal Antibody Concentrations anti-9V, M13	0.3 μg/mL Interval 0.2 to 0.4	0.3 μg/mL Interval 0.2 to 0.4	0.2 μg/mL Interval 0.1 to 0.3
Anti-pneumococcal Antibody Concentrations anti-9V, M14	1.6 μg/mL Interval 1.3 to 2.0	1.0 μg/mL Interval 0.8 to 1.4	1.6 μg/mL Interval 1.2 to 2.2
Anti-pneumococcal Antibody Concentrations anti-14, M13	1.0 μg/mL Interval 0.7 to 1.3	0.8 μg/mL Interval 0.6 to 1.0	0.9 μg/mL Interval 0.5 to 1.4
Anti-pneumococcal Antibody Concentrations anti-14, M14	8.4 μg/mL Interval 6.8 to 10.4	6.8 μg/mL Interval 4.8 to 9.7	9.0 μg/mL Interval 6.0 to 13.5
Anti-pneumococcal Antibody Concentrations anti-18C, M5	2.3 μg/mL Interval 1.9 to 2.8	2.0 μg/mL Interval 1.5 to 2.5	2.9 μg/mL Interval 2.2 to 3.8
Anti-pneumococcal Antibody Concentrations anti-18C, M13	0.2 μg/mL Interval 0.2 to 0.3	0.2 μg/mL Interval 0.1 to 0.3	0.3 μg/mL Interval 0.2 to 0.4
Anti-pneumococcal Antibody Concentrations anti-18C, M14	3.6 μg/mL Interval 3.0 to 4.4	2.3 μg/mL Interval 1.5 to 3.6	3.4 μg/mL Interval 2.6 to 4.6
Anti-pneumococcal Antibody Concentrations anti-19A, M14	1.2 μg/mL Interval 0.8 to 1.7	1.1 μg/mL Interval 0.6 to 1.9	0.8 μg/mL Interval 0.5 to 1.2
Anti-pneumococcal Antibody Concentrations anti-19F, M5	3.7 μg/mL Interval 3.0 to 4.6	3.8 μg/mL Interval 2.7 to 5.3	4.7 μg/mL Interval 3.3 to 6.6
Anti-pneumococcal Antibody Concentrations anti-19F, M13	0.9 μg/mL Interval 0.7 to 1.2	0.9 μg/mL Interval 0.7 to 1.3	0.9 μg/mL Interval 0.5 to 1.5
Anti-pneumococcal Antibody Concentrations anti-23F, M13	0.3 μg/mL Interval 0.2 to 0.4	0.3 μg/mL Interval 0.2 to 0.4	0.2 μg/mL Interval 0.2 to 0.4
Anti-pneumococcal Antibody Concentrations anti-23F, M14	3.4 μg/mL Interval 2.6 to 4.5	2.1 μg/mL Interval 1.3 to 3.4	2.9 μg/mL Interval 1.8 to 4.7

SECONDARY outcome

Timeframe: At Month 5 (one month post-dose 3)

Population: The analysis was performed on a randomized subset of 25% in the primary ATP cohort for immunogenicity who complied with the protocol criteria and for whom data concerning immunogenicity endpoint measures were available, for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination.

Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=72 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=34 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=38 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Anti-diphtheria (Anti-D) Antibodies	72 Participants	34 Participants	38 Participants

SECONDARY outcome

Timeframe: At Month 5 (one month post-dose 3)

Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=72 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=34 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=38 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Concentration of Antibodies Against Diphtheria Antigens (Anti-D)	2.259 IU/mL Interval 1.82 to 2.804	3.028 IU/mL Interval 2.177 to 4.213	2.462 IU/mL Interval 1.7 to 3.565

SECONDARY outcome

Timeframe: At Month 5 (one month post-dose 3)

Population: The analysis was performed on the Primary TVC, which included all vaccinated subjects during the primary phase.

Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=76 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=36 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=39 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Concentration of Antibodies Against Diphtheria Antigens (Anti-D)	2.435 IU/mL Interval 1.958 to 3.028	3.069 IU/mL Interval 2.225 to 4.233	2.423 IU/mL Interval 1.688 to 3.479

SECONDARY outcome

Timeframe: At Month 5 (one month post-dose 3)

Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=73 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=34 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=39 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens anti-PT, M5	49.9 EL.U/mL Interval 43.3 to 57.6	51.9 EL.U/mL Interval 40.8 to 66.0	47.8 EL.U/mL Interval 38.3 to 59.7
Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens anti-FHA, M5	126.2 EL.U/mL Interval 108.8 to 146.3	134.2 EL.U/mL Interval 108.3 to 166.4	132.6 EL.U/mL Interval 107.8 to 163.1
Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens anti-PRN, M5	108.6 EL.U/mL Interval 88.8 to 132.9	167.5 EL.U/mL Interval 117.6 to 238.7	158.2 EL.U/mL Interval 106.5 to 235.1

SECONDARY outcome

Timeframe: At Month 5 (one month post-dose 3)

Population: The analysis was performed on the Primary TVC included all vaccinated subjects during the primary phase.

Cut-off values assessed were greater than or equal to ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=77 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=36 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=40 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Immunoglobulin G (IgG) Antibodies anti-PT, M5	77 Participants	36 Participants	40 Participants
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Immunoglobulin G (IgG) Antibodies anti-FHA, M5	77 Participants	36 Participants	40 Participants
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Immunoglobulin G (IgG) Antibodies anti-PRN, M5	77 Participants	36 Participants	39 Participants

SECONDARY outcome

Timeframe: At Month 5 (one month post-dose 3)

Population: The analysis was performed on the Primary TVC, which included all vaccinated subjects during the primary phase.

Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=77 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=36 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=40 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens anti-PRN, M5	116.7 EL.U/mL Interval 95.2 to 143.1	178.9 EL.U/mL Interval 125.5 to 255.1	154.8 EL.U/mL Interval 105.0 to 228.3
Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens anti-PT, M5	50.4 EL.U/mL Interval 43.9 to 57.8	54.7 EL.U/mL Interval 42.9 to 69.9	46.4 EL.U/mL Interval 37.0 to 58.1
Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens anti-FHA, M5	127.3 EL.U/mL Interval 110.6 to 146.6	143.3 EL.U/mL Interval 114.4 to 179.4	129.4 EL.U/mL Interval 105.1 to 159.2

SECONDARY outcome

Timeframe: At Month 5 (one month post-dose 3)

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=69 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=29 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=33 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies anti-Polio 1, M5	788.8 Titers Interval 584.1 to 1065.2	1102.9 Titers Interval 725.2 to 1677.2	908.6 Titers Interval 549.1 to 1503.4
Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies anti-Polio 2, M5	850.4 Titers Interval 647.3 to 1117.3	953.3 Titers Interval 579.0 to 1569.5	1079.2 Titers Interval 704.9 to 1652.1
Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies anti-Polio 3, M5	1678.8 Titers Interval 1211.2 to 2326.9	1676.7 Titers Interval 1011.1 to 2780.5	1261.3 Titers Interval 720.8 to 2207.1

SECONDARY outcome

Timeframe: At Month 5 (one month post-dose 3)

Population: The analysis was performed on the Primary TVC, which included all vaccinated subjects during the primary phase.

Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=73 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=31 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=34 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies anti-Polio 1, M5	827.2 Titers Interval 618.7 to 1105.8	1048.1 Titers Interval 681.1 to 1612.7	861.0 Titers Interval 523.3 to 1416.8
Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies anti-Polio 2, M5	931.3 Titers Interval 707.7 to 1225.6	990.4 Titers Interval 606.5 to 1617.3	1024.0 Titers Interval 668.6 to 1568.2
Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies anti-Polio 3, M5	1709.5 Titers Interval 1245.4 to 2346.7	1618.7 Titers Interval 963.7 to 2719.0	1184.8 Titers Interval 679.9 to 2064.4

SECONDARY outcome

Timeframe: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)

Population: The analysis was performed on the ATP cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of subjects of all three groups.

Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=77 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=36 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=40 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Anti-tetanus (Anti-T) Antibodies anti-T, M5	77 Participants	36 Participants	40 Participants
Number of Subjects With Anti-tetanus (Anti-T) Antibodies anti-T, M13	58 Participants	28 Participants	24 Participants
Number of Subjects With Anti-tetanus (Anti-T) Antibodies anti-T, M14	62 Participants	22 Participants	23 Participants

SECONDARY outcome

Timeframe: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)

Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=73 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=34 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=39 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Concentration of Antibodies Against Tetanus Antigens (Anti-T) anti-T, M13	0.479 IU/mL Interval 0.398 to 0.576	0.659 IU/mL Interval 0.427 to 1.018	0.461 IU/mL Interval 0.297 to 0.716
Concentration of Antibodies Against Tetanus Antigens (Anti-T) anti-T, M5	5.798 IU/mL Interval 4.998 to 6.726	7.246 IU/mL Interval 5.305 to 9.897	5.973 IU/mL Interval 4.818 to 7.406
Concentration of Antibodies Against Tetanus Antigens (Anti-T) anti-T, M14	18.977 IU/mL Interval 16.013 to 22.489	16.813 IU/mL Interval 12.386 to 22.821	35.835 IU/mL Interval 23.802 to 53.951

SECONDARY outcome

Timeframe: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)

Population: The analysis was performed on the Adapted TVC, which included all vaccinated subjects during the primary phase.

Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=77 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=36 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=40 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Anti-tetanus (Anti-T) Antibodies anti-T, M13	58 Participants	28 Participants	24 Participants
Number of Subjects With Anti-tetanus (Anti-T) Antibodies anti-T, 14	62 Participants	22 Participants	23 Participants
Number of Subjects With Anti-tetanus (Anti-T) Antibodies anti-T, M5	77 Participants	36 Participants	40 Participants

SECONDARY outcome

Timeframe: At Month 5 (one month post-dose 3)

Population: No subjects were analyzed because the endpoints evaluating immunogenicity of the Hib component (anti-polyribosyl ribitol phosphate \[anti-PRP\] antibody concentrations) has been cancelled owing to the extended delay in the re-development and re-validation of the PRP assay.

The endpoints evaluating immunogenicity of the Hib component (anti-polyribosyl ribitol phosphate \[anti-PRP\] antibody concentrations) has been cancelled owing to the extended delay in the re-development and re-validation of the PRP assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 8 days (Day 0-7) post primary vaccination

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase who had their symptom sheets completed.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=369 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=182 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=184 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Swelling Dose 3	66 Participants	46 Participants	37 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Swelling Dose 3	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Redness Dose 2	2 Participants	0 Participants	1 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Swelling Dose 2	76 Participants	47 Participants	42 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Swelling Dose 2	2 Participants	2 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Redness Dose 3	1 Participants	1 Participants	1 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Pain Dose 1	220 Participants	115 Participants	108 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Redness Dose 1	94 Participants	39 Participants	43 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Swelling Dose 1	0 Participants	3 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Pain Dose 2	177 Participants	92 Participants	101 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Pain Dose 2	33 Participants	11 Participants	16 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Redness Dose 2	93 Participants	51 Participants	48 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Pain Across Doses	262 Participants	135 Participants	142 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Pain Across Doses	65 Participants	36 Participants	33 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Redness Across Doses	160 Participants	79 Participants	78 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Redness Across Doses	4 Participants	1 Participants	2 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Swelling Across Doses	3 Participants	4 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Pain Dose 1	38 Participants	25 Participants	14 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Redness Dose 1	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Swelling Dose 1	84 Participants	31 Participants	34 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Pain Dose 3	148 Participants	73 Participants	93 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Grade 3 Pain Dose 3	16 Participants	18 Participants	9 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Redness Dose 3	74 Participants	46 Participants	42 Participants
Number of Subjects With Solicited Local Symptoms (Primary Phase) Any Swelling Across Doses	147 Participants	74 Participants	70 Participants

SECONDARY outcome

Timeframe: Within 8 days (Day 0-7) post booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects at booster time point (at Month 13) who had their symptom sheets completed.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=338 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=165 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=167 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Solicited Local Symptoms (Booster Phase) Grade 3 Pain	21 Participants	19 Participants	14 Participants
Number of Subjects With Solicited Local Symptoms (Booster Phase) Any Redness	74 Participants	32 Participants	39 Participants
Number of Subjects With Solicited Local Symptoms (Booster Phase) Any Swelling	55 Participants	29 Participants	33 Participants
Number of Subjects With Solicited Local Symptoms (Booster Phase) Grade 3 Swelling	2 Participants	1 Participants	3 Participants
Number of Subjects With Solicited Local Symptoms (Booster Phase) Any Pain	139 Participants	71 Participants	77 Participants
Number of Subjects With Solicited Local Symptoms (Booster Phase) Grade 3 Redness	1 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Within 8 days (Day 0-7) post primary vaccination

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase who had their symptom sheets completed.

Assessed solicited general symptoms were temperature \[defined as rectally temperature equal to or above 38 degrees Celsius (°C)\], drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=369 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=182 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=184 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Irritability Dose 1	19 Participants	9 Participants	10 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Loss of appetite Dose 1	109 Participants	62 Participants	42 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Loss of appetite Dose 1	7 Participants	5 Participants	3 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Loss of appetite Dose 1	99 Participants	55 Participants	35 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Temperature Dose 1	126 Participants	62 Participants	58 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Temperature Dose 1	0 Participants	0 Participants	1 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Temperature Dose 1	109 Participants	56 Participants	53 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Drowsiness Dose 2	116 Participants	72 Participants	67 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Drowsiness Dose 2	9 Participants	8 Participants	8 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Drowsiness Dose 2	109 Participants	69 Participants	62 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Irritability Dose 2	20 Participants	14 Participants	10 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Temperature Dose 2	119 Participants	64 Participants	63 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Temperature Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Drowsiness Dose 3	102 Participants	54 Participants	64 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Drowsiness Dose 3	11 Participants	8 Participants	4 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Drowsiness Dose 3	95 Participants	54 Participants	60 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Irritability Dose 3	140 Participants	73 Participants	73 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Irritability Dose 3	132 Participants	72 Participants	69 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Loss of appetite Dose 3	63 Participants	41 Participants	46 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Temperature Dose 3	109 Participants	51 Participants	41 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Temperature Dose 3	2 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Drowsiness Across Doses	217 Participants	121 Participants	118 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Irritability Across Doses	254 Participants	128 Participants	126 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Irritability Across Doses	42 Participants	27 Participants	18 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Loss of appetite Across	165 Participants	89 Participants	82 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Temperature Across Doses	193 Participants	97 Participants	93 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Drowsiness Dose 1	177 Participants	93 Participants	84 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Drowsiness Dose 1	18 Participants	10 Participants	2 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Drowsiness Dose 1	160 Participants	84 Participants	79 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Irritability Dose 1	200 Participants	107 Participants	99 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Irritability Dose 1	188 Participants	96 Participants	89 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Irritability Dose 2	163 Participants	82 Participants	90 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Irritability Dose 2	158 Participants	77 Participants	85 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Loss of appetite Dose 2	89 Participants	50 Participants	44 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Loss of appetite Dose 2	6 Participants	5 Participants	6 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Loss of appetite Dose 2	80 Participants	48 Participants	39 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Temperature Dose 2	116 Participants	59 Participants	54 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Irritability Dose 3	14 Participants	14 Participants	3 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Loss of appetite Dose 3	76 Participants	43 Participants	50 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Loss of appetite Dose 3	7 Participants	6 Participants	3 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Temperature Dose 3	96 Participants	46 Participants	36 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Drowsiness Across Doses	30 Participants	19 Participants	13 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Drowsiness Across Doses	205 Participants	116 Participants	114 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Irritability Across Doses	246 Participants	125 Participants	121 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Loss of appetite Across	17 Participants	13 Participants	10 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Related Loss of appetite Across	151 Participants	84 Participants	77 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Any Temperature Across Doses	203 Participants	102 Participants	101 Participants
Number of Subjects With Solicited General Symptoms (Primary Phase) Grade 3 Temperature Across Doses	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 8 days (Day 0-7) post booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects at booster time point (at Month 13) who had their symptom sheets completed.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=338 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=165 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=167 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Solicited General Symptoms (Booster Phase) Any Drowsiness	79 Participants	46 Participants	43 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Grade 3 Irritability	9 Participants	12 Participants	10 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Related Irritability	106 Participants	52 Participants	60 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Grade 3 Drowsiness	4 Participants	7 Participants	5 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Related Drowsiness	75 Participants	42 Participants	43 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Any Irritability	112 Participants	54 Participants	61 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Any Loss of appetite	69 Participants	37 Participants	39 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Grade 3 Loss of appetite	5 Participants	5 Participants	1 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Related Loss of appetite	60 Participants	34 Participants	37 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Any Temperature	68 Participants	35 Participants	27 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Grade 3 Temperature	2 Participants	1 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Booster Phase) Related Temperature	62 Participants	32 Participants	24 Participants

SECONDARY outcome

Timeframe: Within 31 days (Day 0-30) post each primary vaccine dose

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=376 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=187 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=187 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Unsolicited Adverse Events (AEs) (Primary Phase) Any AE(s) Dose 1	67 Participants	36 Participants	34 Participants
Number of Subjects With Unsolicited Adverse Events (AEs) (Primary Phase) Any AE(s) Dose 2	70 Participants	34 Participants	28 Participants
Number of Subjects With Unsolicited Adverse Events (AEs) (Primary Phase) Any AE(s) Dose 3	97 Participants	49 Participants	45 Participants

SECONDARY outcome

Timeframe: Within 31 days (Day 0-30) post booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects at booster time point (at Month 13).

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=342 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=166 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=170 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Unsolicited Adverse Events (AEs) (Booster Phase)	58 Participants	32 Participants	36 Participants

SECONDARY outcome

Timeframe: From Day 0 to Month 19

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase.

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=376 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=187 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=187 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)	16 Participants	8 Participants	4 Participants

SECONDARY outcome

Timeframe: From Day 0 to Month 19

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Nimenrix 3+1 Group n=376 Participants Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=187 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=187 Participants Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Number of Subjects With Serious Adverse Events (SAEs)	35 Participants	14 Participants	14 Participants

Adverse Events

Nimenrix 3+1 Group

Serious events: 35 serious events

Other events: 334 other events

Deaths: 0 deaths

Nimenrix 1+1 Group

Serious events: 14 serious events

Other events: 169 other events

Deaths: 0 deaths

Nimenrix Control Group

Serious events: 14 serious events

Other events: 169 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Nimenrix 3+1 Group n=376 participants at risk Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix 1+1 Group n=187 participants at risk Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.	Nimenrix Control Group n=187 participants at risk Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Infections and infestations Nasopharyngitis	17.3% 65/376 • Number of events 83 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	14.4% 27/187 • Number of events 42 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	13.9% 26/187 • Number of events 35 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).
General disorders Pain	72.6% 273/376 • Number of events 684 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	75.9% 142/187 • Number of events 351 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	77.5% 145/187 • Number of events 379 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).
Skin and subcutaneous tissue disorders Erythema	47.1% 177/376 • Number of events 335 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	46.5% 87/187 • Number of events 168 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	46.5% 87/187 • Number of events 172 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).
Psychiatric disorders Irritability	69.7% 262/376 • Number of events 616 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	69.5% 130/187 • Number of events 316 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	69.5% 130/187 • Number of events 323 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).
Respiratory, thoracic and mediastinal disorders Cough	6.1% 23/376 • Number of events 25 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	4.3% 8/187 • Number of events 8 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	2.7% 5/187 • Number of events 5 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).
Metabolism and nutrition disorders Decreased appetite	49.2% 185/376 • Number of events 343 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	50.8% 95/187 • Number of events 192 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	50.8% 95/187 • Number of events 175 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).
Gastrointestinal disorders Diarrhoea	9.6% 36/376 • Number of events 38 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	8.0% 15/187 • Number of events 16 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	5.3% 10/187 • Number of events 10 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).
Infections and infestations Pharyngitis	10.4% 39/376 • Number of events 42 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	9.1% 17/187 • Number of events 25 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	14.4% 27/187 • Number of events 32 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).
General disorders Pyrexia	57.2% 215/376 • Number of events 426 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	59.9% 112/187 • Number of events 214 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	59.4% 111/187 • Number of events 192 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).
Nervous system disorders Somnolence	59.6% 224/376 • Number of events 475 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	66.3% 124/187 • Number of events 265 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	64.2% 120/187 • Number of events 258 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).
General disorders Swelling	41.8% 157/376 • Number of events 281 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	44.4% 83/187 • Number of events 153 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).	41.7% 78/187 • Number of events 146 • Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER